PB2111: SUBGROUP ANALYSIS IN RE-MIND2, AN OBSERVATIONAL, RETROSPECTIVE COHORT STUDY OF TAFASITAMAB + LENALIDOMIDE VERSUS SYSTEMIC THERAPIES IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA
Authors: G. S. Nowakowski, D. H. Yoon, E. Joffe, P. L. Zinzani, L. Sabatelli, E. E. Waltl, C. G. Alvero, G. Hess, P. Riedell, K. Kim, D. Brixner, G. Salles
Journal: HemaSphere (2022)

Background: Tafasitamab (tafa) + lenalidomide (LEN) demonstrated efficacy in adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) ineligible for autologous stem-cell transplant in the pivotal Phase II study L-MIND (NCT02399085). The combination received accelerated approval in the United States in 2020 and conditional marketing authorization in Europe and Canada in 2021 in this setting. RE-MIND2 (NCT04697160), an observational, retrospective cohort study compared patient outcomes from L-MIND with matched patient cohorts treated with other NCCN/ESMO recommended therapies. Prolonged overall survival (OS) with tafa + LEN was detected compared to a cohort of systemic therapies for DLBCL pooled (STP), bendamustine + rituximab (BR), rituximab + gemcitabine + oxaliplatin (R-GemOx), polatuzumab vedotin + BR (pola-BR), and rituximab + LEN (R2). Comparable OS was detected versus CD19 CAR-T therapies (CAR-T). However, limited information is available on the comparative effectiveness of tafa + LEN in specific subpopulations. Aims: To inform on the relative effectiveness of tafa + LEN versus other treatment regimens for R/R DLBCL in clinically relevant patient subgroups in the absence of head-to-head trials. Methods: Data were collected from health records of eligible patients aged ≥18 years with histologically confirmed DLBCL, who had received ≥2 systemic therapies for DLBCL (including ≥1 anti-CD20 therapy). Patients from L-MIND were matched with patients from the RE-MIND2 observational cohort using estimated propensity score-based 1:1 nearest neighbor matching, balanced for nine or six covariates. Hypothesis-generating analyses were conducted for patient subgroups of number of extranodal sites (ENS) (0–1 vs ≥2) and elevated lactate dehydrogenase (LDH) (yes vs no) in matched cohorts of patients receiving tafa + LEN vs STP, pola-BR, R2, and CAR-T. The primary endpoint was OS. Results: Of 3,454 patients enrolled, 961, 106, 106, and 149 were treated with STP, pola-BR, R2, and CAR-T, resulting in 76, 24, 33, and 37 matched pairs for patients receiving tafa + LEN, respectively. Hazard ratios (HR) for OS show a trend toward favoring tafa + LEN in most patient subgroups (Table). Image:Summary/Conclusion: These analyses suggest that tafa + LEN may be associated with improved OS vs selected systemic therapies for certain patients with high-risk disease and may further inform physicians’ treatment choices for patients with R/R DLBCL. These analyses are not powered for statistical comparison; small sample sizes in some subgroups result in wide confidence intervals and, although supported by several sensitivity analyses, the observed trends must be interpreted with caution. Additional analyses including other patient subgroups, endpoints, and cohort balancing approaches will be presented.